BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTER SHEATH, 27 FR., 2 STOPCOCKS, ROTATABLE

    MDR report key: 3884149 · Received May 19, 2014

    Report

    Report Number
    9610773-2014-00018
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECTED MEDICAL DEVICES WERE NOT YET RETURNED TO THE MFR FOR EVAL/INVESTIGATION. THEREFORE THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNK. HOWEVER, IF THE SUSPECT MEDICAL DEVICES ARE RETURNED FOR EVAL OR ADD'L SIGNIFICANT INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. THIS REPORT REFERS TO THE SUSPECT MEDICAL DEVICE LABELED AS A22021A IN THE INITIAL REPORT ABOUT THE SAME INCIDENT. CROSS-REFERENCE TO/DUPLICATE OF MFR REPORT # 9610773-2014-00016, 9610773-2014-00017, 9610773-2014-00019. OLYMPUS SUBMITS THIS INCIDENT AS A MEDICAL DEVICE REPORT (MDR) IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TRANSURETHRAL RESECTION (TUR) PROCEDURE, THE CERAMIC INSULATION OF THE RESECTION SHEATH (A22041A) BROKE OFF INSIDE THE PT. NO FRAGMENTS/PARTS REMAINED INSIDE THE OT AS THEY WERE REPORTEDLY RETRIEVED BY UNK APPROACH. THE INTENDED PROCEDURE WAS REPORTEDLY COMPLETED BY USING A SIMILAR DEVICE. THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PT HARM OR INJURY. HOWEVER, IT WAS REPORTED THAT THE PT'S LEGS WERE REPEATEDLY TWITCHING DUE TO THE UNINTENDED STIMULATION OF THE OBTURATOR NERVE. FURTHERMORE, AN IDENTICAL PRODUCT PROBLEM/MALFUNCTION REPORTEDLY OCCURRED AGAIN WITH A RESECTION SHEATH OF THE SAME MODEL (A22041A) BUT FROM A DIFFERENT LOT DURING ANOTHER SUBSEQUENT PROCEDURE. HOWEVER, NO OTHER INFO WAS PROVIDED FOR THE SECOND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296457 OUTER SHEATH, 27 FR., 2 STOPCOCKS, ROTATABLE OUTER SHEATHS FAS OLYMPUS WINTER & IBE GMBH 36W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WORKING ELEMENT, ACTIVE (A22060A)| RESECTION SHEATH, 24 FR. (A22041A)| HF-RESECTION ELECTRODE, BAND, 24 FR. (A22221C)